Medication info
K-Cap Tablets 50 mg (Tezeprazan)

K-Cap Tablets 50 mg (Tezeprazan)

Prescription medicationTabletOral
Ingredient · strength
Tegoprazan›50mg / 1 tablet
Manufacturer / importer
HK inno.N Co., Ltd.
Appearance
Light pink oval film-coated tablet (for export) Light pink asymmetric triangular film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 201802815 · Approved 2018.07.05 · Insurance code 640007270

Summary

Main use
Treatment of gastroesophageal reflux disease and gastric ulcers; Helicobacter pylori eradication therapy
Who takes it
Adults
Adult dose
This medicine is administered to adults as follows. 1. Treatment of erosive gastroesophageal reflux disease Administer 50 mg orally once daily for 4 weeks. For patients whose esophagitis has not healed or whose symptoms persist, administer for an additional 4 weeks. 2. Treatment of non-erosive gastroesophageal reflux disease Administer 50 mg orally once daily for 4 weeks. 3. Treatment of gastric ulcers Administer 50 mg orally once daily for 8 weeks. 4. Concomitant antibiotic therapy for Helicobacter pylori eradication in patients with peptic ulcer disease and/or chronic atrophic gastritis Patients with Helicobacter pylori infection should receive eradication therapy. Administer this medicine 50 mg, amoxicillin 1 g, and clarithromycin 500 mg orally twice daily for 7 days. 5. Maintenance therapy following treatment of erosive gastroesophageal reflux disease <25mg only> Administer 25 mg orally once daily. This medicine may be taken with or without food. Patients with hepatic impairment: No dosage adjustment is necessary in patients with mild hepatic impairment according to the Child-Pugh classification.

Ingredients

Manufacturer
HK inno.N Co., Ltd.

Efficacy & effects

Treatment of gastroesophageal reflux disease and gastric ulcers; Helicobacter pylori eradication therapy

  • Erosive gastroesophageal reflux disease
  • non-erosive gastroesophageal reflux disease
  • gastric ulcers
  • peptic ulcers
  • chronic atrophic gastritis
  • Helicobacter pylori infection
View approved original text

This medicine is used to treat erosive gastroesophageal reflux disease and non-erosive gastroesophageal reflux disease. It is also effective for the treatment of gastric ulcers. It is used in combination with antibiotics to eradicate Helicobacter pylori infection in patients with peptic ulcers or chronic atrophic gastritis. It is also used for maintenance therapy to prevent symptom recurrence after treating erosive gastroesophageal reflux disease. This medication improves the health of the stomach and esophagus and alleviates symptoms, thus enhancing the quality of life for patients.

How to take

Adult dose

This medicine is administered to adults as follows. 1. Treatment of erosive gastroesophageal reflux disease Administer 50 mg orally once daily for 4 weeks. For patients whose esophagitis has not healed or whose symptoms persist, administer for an additional 4 weeks. 2. Treatment of non-erosive gastroesophageal reflux disease Administer 50 mg orally once daily for 4 weeks. 3. Treatment of gastric ulcers Administer 50 mg orally once daily for 8 weeks. 4. Concomitant antibiotic therapy for Helicobacter pylori eradication in patients with peptic ulcer disease and/or chronic atrophic gastritis Patients with Helicobacter pylori infection should receive eradication therapy. Administer this medicine 50 mg, amoxicillin 1 g, and clarithromycin 500 mg orally twice daily for 7 days. 5. Maintenance therapy following treatment of erosive gastroesophageal reflux disease <25mg only> Administer 25 mg orally once daily. This medicine may be taken with or without food. Patients with hepatic impairment: No dosage adjustment is necessary in patients with mild hepatic impairment according to the Child-Pugh classification.

Precautions

This medicine should not be used in certain patients. It is contraindicated in patients with allergies or hypersensitivity to this medication or its components, patients taking certain antiviral medications, and in pregnant or breastfeeding women. This medication should be used cautiously in patients with severely impaired liver function, patients with kidney function problems, and in elderly patients. Various side effects may occur during the use of this medication. The most common side effects include nausea, diarrhea, and dyspepsia, and cold symptoms or chest discomfort have also been reported. Rarely, muscle pain, headache, dizziness, skin rash, cough, and insomnia may occur, so if abnormal symptoms appear, patients should consult a doctor. Long-term use of this medication may lead to vitamin B12 deficiency, so regular testing is necessary for prolonged use. Additionally, because this medication suppresses gastric acid, the risk of bacterial infection in the gastrointestinal tract may slightly increase, so if gastrointestinal symptoms such as diarrhea persist, patients should inform their healthcare provider. This medication can interact with other drugs, so if patients are taking any other medications, they must inform their doctor or pharmacist. It is safest not to take this medication during pregnancy or breastfeeding, and its safety in children and adolescents has not been sufficiently established. Elderly patients or those with decreased kidney function should exercise additional caution when using this medication. In case of overdose, there is no specific treatment, but symptoms should be monitored and general treatment should be administered if necessary. This medication should be stored out of reach of children, and it is advisable not to transfer it to other containers.

Side effects

Nausea, diarrhea, dyspepsia, nasopharyngitis, viral upper respiratory infection, chest discomfort, epigastric pain, abdominal discomfort, constipation, abdominal pain, abdominal distension, vomiting, belching, lower abdominal pain, gastric ulcer, anal bleeding, erosive duodenitis, flatulence, gastric polyps, gastroesophageal reflux disease, intestinal metaplasia, hematemesis, hemorrhoids, melena, folliculitis, bacterial gastroenteritis, latent tuberculosis, elevated alanine aminotransferase, elevated gamma-glutamyl transferase, increased blood bilirubin, elevated aspartate aminotransferase, increased blood creatine phosphokinase, presence of hematuria, positive urinary red blood cells, increased blood gastrin, increased blood triglycerides, fatigue, ligament sprain, concussion, abrasion, foot fracture, joint injury, muscle strain, myalgia, arthralgia, tendinitis, headache, dizziness, vascular edema, dermatitis, seborrheic dermatitis, cough, oropharyngeal pain, throat irritation, vaginal discharge, vulvar pruritus, breast calcification, adenomyosis, ovarian cyst, bile duct stones, liver cysts, overactive bladder, nocturia, kidney cyst, gastric adenocarcinoma, breast cancer, gastrointestinal adenoma, uterine leiomyoma, ventricular premature contractions, lymphadenitis, anemia, insomnia, dental implants, otalgia, diabetes mellitus, hypertension, thyroid cyst, diarrhea, epigastric pain, abdominal distension, dyspepsia, abdominal pain, taste disturbance, headache, urticaria, dry mouth, anal incontinence, oral sensory disturbance, migraine, drowsiness, pruritus, erythema, rash, drug rash, toxic skin rash, cystitis, herpes zoster, molluscum contagiosum, sinusitis, tonsillitis, asthenia, chest pain, low back pain, musculoskeletal stiffness, vocal disturbance, palpitations, flushing, facial flushing, choroiditis, retinal disorder, facial paralysis, sensory disturbance, cystitis, bronchitis, periodontitis, scoliosis, musculoskeletal discomfort, intervertebral disc disorder of the spine, bone loss, arthralgia, low back pain, bruise, pelvic fracture, skin abrasion, tooth fracture, wrist fracture, chronic urticaria, diastolic dysfunction, hearing loss, thyroid mass, nephrolithiasis, limb pain

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly closed container to protect it from air or moisture. The storage temperature should be maintained between 1°C and 30°C.

Appearance and packaging

Appearance

Light pink oval film-coated tablet (for export) Light pink asymmetric triangular film-coated tablet

Package unit

30 tablets/bottle, 300 tablets/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.